Participant Indentification Centres (PICs)A practical guide for primary care

Delivering research to make patients, and the NHS, better

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What is a PIC? 4

What is a PIC responsible for? 6

Is a PIC considered to be a research site? 7

What will the PIC be asked to do? 8

What should the recruiting site do? 10

What should the sponsor/study team do? 11

Contact us 12

Contents

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What is a PIC?Clinical studies often require the use of Participant Identification Centres (PIC). A PIC is a site where participants are identified and referred to a different centre specifically to take part in a research study. The receiving centre is the research site and is responsible for the subsequent assessment of potential participants, and taking informed consent to enter the participant into the study.

The process of using PICs can be helpful when there are unlikely to be sufficient numbers of patients presenting at the research site. It is a way of opening out recruitment of a study beyond the confines of the research site and allows patients from neighbouring sites to be given access to take part in research. The recruiting site can be a university, a primary care site, secondary care site or tertiary care site and the PIC can be from within the same sector as the recruiting site or from a different sector. Traditionally we think of primary care sites referring to secondary care sites, but the approach applies equally to secondary care to secondary care and primary care to primary care.

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Possible research scenarios:

• The study may be taking place in a hospital, due to the complexity of the protocol, but may require local GPs to search their database for patients who meet the inclusion/exclusion criteria for the study to send them an information pack about the study. If the patient, on reading the information, is keen to take part in the study, they are requested to contact the study team at the hospital to discuss.

• The study may involve a rare patient group such that the numbers of participants that can be recruited from one site are so low that it is necessary to recruit from multiple sites but refer into the one centre for the study.

• The study may require GPs to identify patients to receive questionnaires/letters for a study that is coordinated by a team based at a university.

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PICs are responsible for the identification of potential participants who are subsequently invited to take part in research at a different site which takes on responsibility for seeking consent and undertaking research procedures. PIC sites do nothing more than the identification of participants which often includes a database search and a mail out of an invitation letter, but may involve opportunistic identification. If a site is involved in anything further (taking consent, passing on research data, follow-up of patients) then they would be formally classed as a research site and would need to apply for full R&D permissions to undertake the research.

The PIC retains responsibility for the healthcare of the patient outside the research, but the research site takes on the duty of care for them in relation to the research study.

The PIC is not responsible for undertaking the research procedures specified in the research protocol, for maintaining the safety of the participants in relation to the delivery of the protocol or for providing indemnity or insurance for the research procedures specified in the protocol.

The application for agreement to act as a PIC for a study using the NIHR Coordinated System for gaining NHS Permission (CSP) consists solely of the study-wide documents. A Site-Specific Information (SSI) Form or local versions of documents are not required. Agreement to act as a PIC may take place before or in parallel with NHS Permission from research sites.

What is a PIC responsible for?

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As a PIC is not responsible for the delivery of research procedures, it is not classed as a research site.

Research sites are defined as organisations responsible for conducting research procedures specified in the protocol, such as, screening, taking informed consent and conducting intervention(s).

Is a PIC considered to be a research site?

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What will a PIC be asked to do? The study team or Network staff should provide the PIC site with a short summary of the study along with the main inclusion/exclusion criteria for the study. Also included in this summary will be information on reimbursement for the work undertaken. For primary care, a PIC is likely to undertake the following activities.

Database searchThe database search criteria comprises of the inclusion and exclusion criteria for the research study. For some studies the search has already been created in the form of a programme which will need to be run on the practice system. For others the practice briefing will list the criteria or there will be a separate listing provided by the researchers and the practice will build its own search. Sometimes the search will be possible to complete using just the practice database, but sometimes, if inclusion or exclusion criteria are not coded then this will require some searching of the patient’s paper records.

GP checksThe record/note searches will only identify those patients that meet the specified inclusion and exclusion criteria. However, there may be other reasons why it may not be appropriate to invite the patient to take part in a research study. Therefore, it is the responsibility of the patient’s GP to review the list of potential participants to remove the names of those patients who should not be contacted. The following should be considered when finalising the list of potential participants although it is dependent on the type of study:

• Suitability for receiving a mail shot • Suffered a recent bereavement • Issues within the family – other serious illness, etc.• Have another ailment such as Hep B or severe mental health issues• In a care home/hospice• Involved in another study

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Mail shotOnce the GP search and check has identified the final list of potential participants, they are contacted via a mailing (usually using envelopes and postage stamps provided by the research team/study sponsor). All letters of invitation should be sent out on practice headed paper. An electronic version of the invitation letter is often provided by the research team/study sponsor to the Practice. The invitation letter will have been approved by an NHS Research Ethics Committee and must not be altered.

Opportunistic participant identificationSometimes the GP will be asked to opportunistically identify patients during consultations rather than undertake a note search and send invitation letters. If patients who meet the relevant criteria for the study are identified, the GP can discuss the study with the potential participant and provide them with further information details about the study. If the patient is interested in taking part they are able to contact the research site to discuss further.

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What should the recruiting site do?

A secondary care site or GP practice who wishes to recruit to a research study by working with PICs needs to give careful thought and consideration to the planning of this approach to recruitment. Some key things to bear in mind include:

• During the feasibility process liaise with some of the potential sites acting as a PIC to discuss the details of the study, especially the inclusion and exclusion criteria in advance of setting a recruitment target. The feedback from the PICs will assist in setting a realistic recruitment target.

• Involve the PIC in the study set up process. Ensure that all relevant PIC authorisations are in place and ensure that the sponsor has considered a budget to cover the activities at the PIC(s).

• Keep in contact with the sites acting as PICs for the research site during the study and provide them with regular recruitment progress updates.

Please contact your CRN: Primary care representative or the study team if you have any questions related to your PIC activities, our contact details are on the back of this booklet

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What should the sponsor/study team do?

It is the responsibility of the research sponsor to ensure that:

• The PIC approach to recruitment is detailed in the study application forms completed using the Integrated Research Application System (IRAS)

• The participant invitation letter provided by PIC to potential participants has been approved by the NHS Research Ethics Committee

• The site has agreed to act as a PIC

• Correct PIC authorisations are in place (this can be done via the NIHR Coordinated System for gaining NHS Permission (CSP) in liaison with the lead Local Clinical Research Network (see www.crn.nihr.ac.uk/networks)

• The PIC is remunerated for their activities. This is to cover for example, the time spent on undertaking the note search (database and sometimes patient notes), GP checking the list of the potential participants, preparing and sending the invitation letters, postage costs, etc. These costs must be included on the study Costings template, which are available from the NIHR Clinical Research Network website: http://www.crn.nihr.ac.uk/can-help/life-sciences-industry/setup-service/

Please contact your CRN: Primary care representative or the study team if you have any questions related to your PIC activities, our contact details are on the back of this booklet

Contact us

www.crn.nihr.ac.uk/primary_care

To find your local Primary care Specialty lead,go to: www.crn.nihr.ac.uk/primary_care or scan the QR code

Information about other Clinical Research Network specialties can be found on the Clinical Research Network website: www.crn.nihr.ac.uk

If you are seeking support for commercial contract research please get in touch:

Phone: 00 44 113 34 34 555Email: supportmystudy@nihr.ac.ukWeb: www.supportmystudy.nihr.ac.uk